About Us

EmpiriQA LLC provides compliance insights to FDA-regulated in vitro diagnostic (IVD), pharmaceutical, and medical device companies for ensuring safety and quality standards.  We use a goal-oriented, facilitative, team-based approach to deliver practical solutions to complex problems. Using a combination of multidisciplinary technical expertise and persuasive information presentation, our subject matter experts (SME) empower our client stakeholders, management, scientists, and engineers to meet ambitious project commitments in a cost-effective and timely manner.

WHO WE ARE

OUR PROMISE

WHY CHOOSE US

We work in close partnership with our clients to develop and implement effective compliance solutions that meet FDA expectations and customer trust.  Our SMEs work hands-on with our clients in building compliance awareness and quality during each stage of product development, from concept to validation, and assisting in FDA audits on behalf of our clients.
EmpiriQA’s team of seasoned SMEs have the technical qualifications, in-depth understanding of regulatory guidelines, and project management skills to successfully execute our clients’ projects on time and within budget.  With our proven success in working with major biotech, pharmaceutical, and medical device corporations as well start-up, small, and mid-size companies, we have the ability and skills to meet the unique needs of our clients.
EmpiriQA is uniquely qualified to meet the objectives of our clients’ statistical, technical, quality, regulatory, and compliance needs.  We also help identify additional value for existing assets and capabilities, thus potentially creating new and compelling business models.